WO2019091713A1 - Appareil orthopédique et conducteur pour un tel appareil - Google Patents

Appareil orthopédique et conducteur pour un tel appareil Download PDF

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Publication number
WO2019091713A1
WO2019091713A1 PCT/EP2018/078232 EP2018078232W WO2019091713A1 WO 2019091713 A1 WO2019091713 A1 WO 2019091713A1 EP 2018078232 W EP2018078232 W EP 2018078232W WO 2019091713 A1 WO2019091713 A1 WO 2019091713A1
Authority
WO
WIPO (PCT)
Prior art keywords
orthopedic device
conductor
electrical
core
elastomer
Prior art date
Application number
PCT/EP2018/078232
Other languages
German (de)
English (en)
Inventor
Mario KOPPE
Original Assignee
Ottobock Se & Co. Kgaa
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ottobock Se & Co. Kgaa filed Critical Ottobock Se & Co. Kgaa
Priority to CN201880071957.1A priority Critical patent/CN111526840A/zh
Priority to EP18789099.1A priority patent/EP3706669B1/fr
Priority to US15/733,053 priority patent/US11931272B2/en
Publication of WO2019091713A1 publication Critical patent/WO2019091713A1/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50Prostheses not implantable in the body
    • A61F2/78Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
    • A61F2/80Sockets, e.g. of suction type
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50Prostheses not implantable in the body
    • A61F2/5044Designing or manufacturing processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50Prostheses not implantable in the body
    • A61F2/68Operating or control means
    • A61F2/70Operating or control means electrical
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50Prostheses not implantable in the body
    • A61F2/68Operating or control means
    • A61F2/70Operating or control means electrical
    • A61F2/72Bioelectric control, e.g. myoelectric
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50Prostheses not implantable in the body
    • A61F2/78Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50Prostheses not implantable in the body
    • A61F2/78Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
    • A61F2/7812Interface cushioning members placed between the limb stump and the socket, e.g. bandages or stockings for the limb stump
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/0404Electrodes for external use
    • A61N1/0408Use-related aspects
    • A61N1/0452Specially adapted for transcutaneous muscle stimulation [TMS]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/0404Electrodes for external use
    • A61N1/0472Structure-related aspects
    • A61N1/0484Garment electrodes worn by the patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36003Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of motor muscles, e.g. for walking assistance
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50Prostheses not implantable in the body
    • A61F2/68Operating or control means
    • A61F2/70Operating or control means electrical
    • A61F2002/701Operating or control means electrical operated by electrically controlled means, e.g. solenoids or torque motors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50Prostheses not implantable in the body
    • A61F2/68Operating or control means
    • A61F2/70Operating or control means electrical
    • A61F2002/704Operating or control means electrical computer-controlled, e.g. robotic control
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50Prostheses not implantable in the body
    • A61F2/76Means for assembling, fitting or testing prostheses, e.g. for measuring or balancing, e.g. alignment means
    • A61F2002/7615Measuring means

Definitions

  • the invention relates to an orthopedic device having a base body made of an electrically insulating material and at least one electrical conductor, which is arranged on or in the base body.
  • the invention also relates to a conductor for such an orthopedic device and a method for producing such a conductor.
  • orthopedic technical devices are in particular orthoses, prostheses, in particular prosthetic stems and prosthesis liners, or other rehabilitation devices.
  • Orthopedic devices today are often equipped with electrodes to remove myoelectric signals and transmit them to a data processing device or to conduct electrical stimulation signals to the skin and / or an underlying muscle of the patient, ie the wearer of the orthopedic device. This is particularly advantageous in the case of prosthetic liners since they come into direct contact with the skin of the wearer and are therefore particularly suitable as a support for corresponding electrodes.
  • the present invention is not limited to prosthetic liners.
  • the liner often has electrically conductive feedthroughs, for example in the form of metal rivets or electrically conductive silicone regions, so that the orthopedic device has been made electrically conductive in the region of the electrodes.
  • the electrodes must be arranged exactly at the point at which the passages in the orthopedic device are arranged and also directly at the point where they must be arranged on the carrier, for example on an amputation stump ,
  • the often space-intensive electrodes can therefore often not be placed at the optimum location.
  • a method is known in which a prosthesis liner is equipped with electrically conductive conductors.
  • the base body is initially produced from an electrically insulating elastomer material. This is networked. Subsequently, structures are introduced into the first molded elastomeric material, which serve as a mold for the electrical wires. In these structures, a second elastomeric material is then introduced, which is electrically conductive and then crosslinked. In this way, an electrical conductor is made of an electrically conductive elastomer material, which is arranged in recesses in the base body.
  • the invention is therefore the object of an orthopedic device according to the preamble of claim 1 further develop so that on , ,
  • the invention solves this problem by an orthopedic device according to the preamble of claim 1, which is characterized in that the at least one conductor has a core of an electrically conductive elastomer and an electrically insulating coating.
  • Such a conductor may be in the form of a cable or a cord, for example.
  • the elastomer of the core can be made electrically conductive, for example, by adding particles.
  • a coating of an electrically insulating material is applied on such a shaped core, for example in the form of the aforementioned cord or cable.
  • the coating does not affect the elastic and flexible properties of the core, so that they correspond to the elastic and flexible properties of the electrical conductor.
  • This conductor can now be easily arranged in or on the base body of the orthopedic device, for example, cast in an elastomeric material of a prosthetic liner. Since in this case both the core of the electrical conductor and the electrically insulating material of the main body is an elastomer, elastic properties of the orthopedic device are not impaired.
  • an elastomer of the core is a silicone, a thermoplastic elastomer or a polyurethane in which graphite, carbon black and / or metal particles and / or carbon nanotubes are located.
  • conductive fibers may also be used.
  • the electrically insulating coating comprises or consists of a parylene.
  • parylene as an insulating coating also has the advantage that, in particular in the event that both the electrically insulating material of the base body and the electrically conductive elastomer of the conductor are a polyurethane or a silicone, also acts as a bonding agent.
  • the parylene coating not only achieves an electrically insulating effect, but also ensures good adhesion between the material of the basic body of the orthopedic device and the electrical conductor.
  • the material of the main body preferably comprises or consists of a silicone, a thermoplastic elastomer or a polyurethane.
  • the orthopedic device has at least one electrode and / or at least one sensor, the electrode and / or the sensor being electrically connected to the at least one conductor and preferably arranged such that it is in the state applied to a body part of the device with the body part comes into contact.
  • the at least one sensor preferably has a pressure sensor, a temperature and / or a humidity sensor, a pulse measuring and / or a blood flow measuring sensor (NIRS) and / or a sensor for measuring the blood sugar level.
  • NIRS blood flow measuring sensor
  • a distance to the skin can also be maintained if the electrode and / or the sensor operates capacitively or inductively.
  • At least one conductor has a shield of an electrically conductive elastomer, which is arranged on the side facing away from the core of the insulating coating.
  • the electrical conductor is thus constructed in three layers from radially inward to radially outward and initially has the core of electrically conductive material, preferably an elastomer, which is covered by the electrically insulating coating on the outside of which the shielding is located. In this way it is possible to produce a kind of a coaxial cable shielded electrical conductor, which is the elastic , ,
  • the shield comprises or consists of the same material as the core of the electrical conductor.
  • the invention also solves the problem posed by a conductor for an orthopedic device described here.
  • the invention also achieves the stated object by a method for producing such a conductor, which is characterized in that the coating is produced by a CVD method.
  • CVD stands for "chemical vapor deposition” and denotes a chemical coating process known to the person skilled in the art.
  • Figure 1 - a schematic sectional views through a conductor for a orthopedic device according to a first embodiment of the present invention
  • FIG. 1 shows in the left-hand illustration a section through an electrical conductor 2 for an orthopedic device according to a first exemplary embodiment of the present invention.
  • the electrical conductor 2 has a core 4 made of an electrically conductive elastomer, for example, a silicon containing graphite particles.
  • the core 4 is surrounded by a coating 6, which consists of an electrically insulating material, such as parylene. , ,
  • an electrical conductor 2 is shown, in which the core 4 is surrounded by the surrounding coating 6 of a shield 8, which also consists of an electrically conductive elastomer and on the side facing away from the core 4 of the insulating Coating 6 is arranged.
  • a shield 8 which also consists of an electrically conductive elastomer and on the side facing away from the core 4 of the insulating Coating 6 is arranged.
  • an electrical conductor 2 is shown which, as in the middle illustration, has a shield 8, which however is now surrounded by a second coating 10.
  • the second coating 10, like the coating 6, is an electrically insulating coating, which advantageously consists of the same material as the coating 6.
  • FIG. 2 shows an orthopedic device in the form of a knee bandage. It has a base body 12, which may be made of an elastic textile, for example, and may have thickening, pads or inserted or incorporated upholstery elements.
  • a base body 12 which may be made of an elastic textile, for example, and may have thickening, pads or inserted or incorporated upholstery elements.
  • six electrodes 14 are incorporated in the main body 12, which are each connected to an electrical conductor 2.
  • the electrical conductors 2 connect the electrodes 14 to an electrical control 16, which is shown schematically in FIG.
  • the electric control 16 is set up to further process electrical signals which are sent from the electrodes 14 via the electrical conductors 2 to the electric control 16 and, if appropriate, to transmit them to an electronic data processing device. This can happen, for example, via cables not shown in FIG.
  • the electronic data processing device is arranged in the electrical control 14 or at least on the main body 12 of the orthopedic device.
  • FIG. 3 shows an orthopedic device according to a further exemplary embodiment of the present invention in the form of a lower leg prosthesis.
  • the main body 12 is in the form of a prosthesis shaft, on which the electrodes 14 are arranged and connected via electrical conductors 2 to an electrical control, which is not shown.
  • On the main body 12 is a lower leg member 18 and an artificial foot 20.
  • myoelectric signals can be removed from an amputation stump, which is arranged in the base body 12. These myoelectric signals are routed through the electrical conductors 2 for electrical control and used to control the artificial foot 18.
  • FIG. 4 shows a further embodiment of an orthopedic device according to an embodiment of the present invention, which is likewise designed as a prosthesis, but now as a hand prosthesis and forearm prosthesis.
  • the base body 12 forms a prosthesis shaft, on which the electrodes 14 are arranged and connected via electrical conductors 2 to the electrical controller 16.
  • the electrical control 16 is set up to generate control signals for a prosthetic hand 22 from the electrical signals picked up by the electrodes 14 and thus to control functions of the prosthetic hand 22.
  • the orthopedic device shown in Figure 4 also has a power supply 24 through which the electrical controller 16 can be supplied with electrical power.
  • FIG. 5 shows an embodiment of an orthopedic device which is designed as a shoulder orthosis.
  • the main body 12 extends beyond the shoulder region of the carrier 26 along the arm of the carrier 26 beyond the elbow.
  • the main body 12 has a fastening strap 28 which is guided around the torso of the carrier 24. Both on the fastening belt 28, which is part of the main body 12, as well as on other parts of the basic , ,
  • FIG. 6 shows an orthopedic device in the form of a T-shirt, the basic body 12 forming the T-shirt itself. Both on sleeves 34 and the rest of the base body 12 electrodes 14 are arranged, which are connected via electrical conductors 2 to the electrical controller 16.
  • the difficulty with this embodiment of the orthopedic device is that the best possible contact between the electrodes 14 and the skin area of the
  • To build carrier 24 This can be done for example via the cut of the T-shirt, an elastic material or incorporated straps.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Manufacturing & Machinery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un appareil orthopédique comprenant un corps de base constitué d'un matériau électriquement isolant et au moins un conducteur électrique qui est placé sur ou dans le corps de base. Selon l'invention, ledit au moins un conducteur comprend une âme constituée d'un élastomère électriquement conducteur et un revêtement électriquement isolant.
PCT/EP2018/078232 2017-11-10 2018-10-16 Appareil orthopédique et conducteur pour un tel appareil WO2019091713A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CN201880071957.1A CN111526840A (zh) 2017-11-10 2018-10-16 矫形技术装置和用于其的导体
EP18789099.1A EP3706669B1 (fr) 2017-11-10 2018-10-16 Dispositif orthopédique avec conducteur électrique
US15/733,053 US11931272B2 (en) 2017-11-10 2018-10-16 Orthopedic device and conductor for such a device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102017126465.5A DE102017126465B4 (de) 2017-11-10 2017-11-10 Orthopädietechnische Einrichtung und Leiter für eine solche sowie Herstel-lungsverfahren
DE102017126465.5 2017-11-10

Publications (1)

Publication Number Publication Date
WO2019091713A1 true WO2019091713A1 (fr) 2019-05-16

Family

ID=63896166

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2018/078232 WO2019091713A1 (fr) 2017-11-10 2018-10-16 Appareil orthopédique et conducteur pour un tel appareil

Country Status (5)

Country Link
US (1) US11931272B2 (fr)
EP (1) EP3706669B1 (fr)
CN (1) CN111526840A (fr)
DE (1) DE102017126465B4 (fr)
WO (1) WO2019091713A1 (fr)

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DE102017126465B4 (de) * 2017-11-10 2022-01-13 Ottobock Se & Co. Kgaa Orthopädietechnische Einrichtung und Leiter für eine solche sowie Herstel-lungsverfahren
EP4309898A3 (fr) 2018-10-04 2024-04-17 Ottobock SE & Co. KGaA Méthode de fabrication d'un appareil orthopédique
CN113164265A (zh) 2018-11-12 2021-07-23 奥索冰岛有限公司 包含基于细丝的结构的医疗器材
EP4057947A1 (fr) 2019-11-12 2022-09-21 Ossur Iceland Ehf Doublure de prothèse ventilée
CN111956380B (zh) * 2020-08-26 2021-05-11 四川大学华西医院 一种压力和温度识别的残端塑型器

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US11931272B2 (en) 2024-03-19
US20200289295A1 (en) 2020-09-17
DE102017126465A1 (de) 2019-05-16
EP3706669B1 (fr) 2023-08-23
CN111526840A (zh) 2020-08-11
DE102017126465B4 (de) 2022-01-13

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